Registro, evaluación, autorización y restricción de sustancias y preparados químicos

IFRA sup­ports kee­ping REACH’s core legis­la­ti­ve text unchan­ged, and ins­tead focu­sing on secon­dary legis­la­tion, tar­ge­ted upda­tes to anne­xes, gui­dan­ce and bet­ter regu­la­tory coor­di­na­tion to make REACH work bet­ter in prac­ti­ce. This mat­ters for a sec­tor made up of more than 750 SMEs along­si­de glo­bal com­pa­nies, supplying ingre­dients used in over 500,000 con­su­mer products.

IFRA’s recom­men­da­tions at a glance:

1. Enhan­ce dia­lo­gue and align­ment with CLP

At sta­ke: Over­lap­ping REACH and CLP eva­lua­tions, and limi­ted dia­lo­gue with ECHA and Mem­ber Sta­tes, crea­te con­fu­sion and unpredictability.

Key ask: Strengthen coor­di­na­tion bet­ween REACH and CLP pro­ces­ses, and struc­tu­re dia­lo­gue with ECHA and Mem­ber States.

2. Pro­por­tio­na­te rules for low-ton­na­ge substances

At sta­ke: More than half of regis­te­red fra­gran­ce subs­tan­ces, and 80 % of natu­ral com­plex subs­tan­ces such as essen­tial oils, fall in the lowest ton­na­ge bands.

Key ask: Keep infor­ma­tion requi­re­ments pro­por­tio­na­te to actual expo­su­re, bac­ked by SME and com­pe­ti­ti­ve­ness impact assessments.

3. An expo­su­re-based prio­ri­ti­za­tion roadmap

At sta­ke: Broad res­tric­tions with tem­po­rary exem­ptions crea­te uncer­tainty and risk remo­ving safely used ingre­dients (e.g. etha­nol) without regard to actual exposure.

Key ask: Assess use and expo­su­re data up front, and set a clear prio­ri­ti­za­tion road­map befo­re new restrictions.

4. No blan­ket Mix­tu­re Assess­ment Fac­tor (MAF)

At sta­ke: An IFRA-com­mis­sio­ned case study esti­ma­tes a gene­ric MAF (fac­tor of 10) could cut sec­tor tur­no­ver by 33 %, without reliably impro­ving safety.

Key ask: Oppo­se a blan­ket MAF; assess com­bi­ned expo­su­re case by case, on a scien­ti­fic basis.

5. Acce­le­ra­te regu­la­tory accep­tan­ce of relia­ble ani­mal-free approaches

At sta­ke: Ani­mal tes­ting remains hea­vily requi­red under REACH and expo­su­re-based alter­na­ti­ves are often limi­ted; new CLP hazard clas­ses risk increa­sing this demand further whi­le New Approach Metho­do­lo­gies (NAMs) are still under development.

Key ask: Sup­port the vali­da­tion of relia­ble NAMs and Next Gene­ra­tion Risk Assess­ment (NGRA) approa­ches and allow more fle­xi­bi­lity for expo­su­re exem­ptions and read-across, whi­le ensu­ring ani­mal tes­ting remains avai­la­ble whe­re­ver no vali­da­ted alter­na­ti­ve yet exists.

6. Stream­li­ned implementation

At sta­ke: Frag­men­ted enfor­ce­ment and com­plex, uns­ta­ble IT sys­tems (e.g. IUCLID) rai­se costs and crea­te mar­ket barriers, espe­cially for SMEs.

Key ask: Ensu­re con­sis­tent enfor­ce­ment across Mem­ber Sta­tes, allow three-year ave­ra­ge volu­mes for regis­tra­tion, and sim­plify IT systems.